Cleared Traditional

K903854 - RAPITEX ASL NEW

K903854 is the FDA 510(k) clearance for RAPITEX ASL NEW by Behring Diagnostics, Inc.. It is a Class 1 Microbiology device (product code GTQ) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K903854 · Behring Diagnostics, Inc. · Microbiology device
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Jan 1991
Decision
160d
Days
Class 1
Risk

K903854 is an FDA 510(k) clearance for the RAPITEX(R) ASL NEW. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on January 28, 1991 after a review of 160 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3720 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K903854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date January 28, 1991
Days to Decision 160 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 102d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTQ Antistreptolysin - Titer/streptolysin O Reagent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3720
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GTQ Antistreptolysin - Titer/streptolysin O Reagent

All 18
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K903854.
QM300 CALIBRATOR G PACK
K910885 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1991
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
K910886 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1991
QM300 CONTROL G PACK
K910887 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1991
ASO-CUBE(TM)
K901371 · Difco Laboratories, Inc. · May 1990
LASER ASO KIT
K854039 · Behring Diagnostics, Inc. · Oct 1985
ASO SLIDE EIKEN
K853276 · Syn-Kit, Inc. · Aug 1985